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Oral Argument Not Yet Scheduled No. 15-1385 (consolidated with 15-1392, 15-1490, 15-1491 & 15-1494) IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT MURRAY ENERGY CORPORATION, Petitioner, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, Respondent. ________________________________ On Petition for Review of Final Agency Action of the United States Environmental Protection Agency 80 FED. REG. 65,292 (OCT. 26, 2015) ________________________________ STATE PETITIONERS’ OPENING BRIEF Brad D. Schimel Attorney General Misha Tseytlin Solicitor General Counsel of Record Daniel P. Lennington WISCONSIN DEPARTMENT OF JUSTICE 17 W. Main Street Madison, WI 53707 (608) 267-9323 Counsel for the State of Wisconsin Mark Brnovich Attorney General John R. Lopez, IV Solicitor General Dominic E. Draye Deputy Solicitor General Counsel of Record Keith Miller OFFICE OF THE ATTORNEY GENERAL 1275 W. Washington Street Phoenix, AZ 85007 (602) 542-8255 Counsel for the State of Arizona Additional counsel listed on following pages USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 1 of 86

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Oral Argument Not Yet Scheduled

No. 15-1385 (consolidated with 15-1392, 15-1490, 15-1491 & 15-1494)

IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT

MURRAY ENERGY CORPORATION,

Petitioner,

v.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,

Respondent.

________________________________

On Petition for Review of Final Agency Action of the United States Environmental Protection Agency

80 FED. REG. 65,292 (OCT. 26, 2015) ________________________________

STATE PETITIONERS’ OPENING BRIEF

Brad D. Schimel Attorney General Misha Tseytlin Solicitor General Counsel of Record Daniel P. Lennington WISCONSIN DEPARTMENT OF

JUSTICE 17 W. Main Street Madison, WI 53707 (608) 267-9323 Counsel for the State of Wisconsin

Mark Brnovich Attorney General John R. Lopez, IV Solicitor General Dominic E. Draye Deputy Solicitor General Counsel of Record Keith Miller OFFICE OF THE ATTORNEY GENERAL 1275 W. Washington Street Phoenix, AZ 85007 (602) 542-8255 Counsel for the State of Arizona

Additional counsel listed on following pages

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 1 of 86

Peter S. Glaser Carroll W. “Mack” McGuffey Darren W. Dwyer TROUTMAN SANDERS LLP 401 Ninth Street, N.W. Washington, D.C. 20004 (202) 274-2952 Counsel for the State of Arizona

Leslie C. Rutledge Attorney General Lee Rudofsky Solicitor General Counsel of Record Jamie L. Ewing Assistant Attorney General 323 Center Street Suite 200 Little Rock, AR 72201 (501) 682-2637 Counsel for the State of Arkansas

Andy Beshear Attorney General Joseph A. Newberg, II Assistant Attorney General Counsel of Record KENTUCKY OFFICE OF THE ATTORNEY GENERAL The Capitol Building 700 Capitol Avenue, Suite 118 Frankfort, Kentucky 40601 (502) 696-5611 Counsel for the Commonwealth of Kentucky

Jeff Landry Attorney General Steven B. “Beaux” Jones Counsel of Record Duncan S. Kemp, IV Assistant Attorneys General Louisiana Department of Justice 1185 North Third Street Baton Rouge, LA 70802 (225) 326-6085 Counsel for the State of Louisiana

Lara Katz Assistant General Counsel Counsel of Record 1190 St. Francis Drive Santa Fe, New Mexico 87505 (505) 827-2885 Counsel for New Mexico Environment Department

Wayne Stenehjem Attorney General Margaret I. Olson Assistant Attorney General Counsel of Record 500 North 9th Street Bismarck, ND 58501-4509 (701) 328-3640 Counsel for the State of North Dakota

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 2 of 86

E. Scott Pruitt Attorney General P. Clayton Eubanks Deputy Solicitor General Counsel of Record 313 N.E. 21st St Oklahoma City, OK 73105 (405) 521-3921 Counsel for the State of Oklahoma Sean Reyes Attorney General Parker Douglas Chief Federal Deputy & General

Counsel Counsel of Record UTAH ATTORNEY GENERAL’S OFFICE

350 North State Street, Ste. 230 Salt Lake City, UT 84114-2320 (801) 538-9600 Counsel for the State of Utah

Ken Paxton Attorney General Jeffrey C. Mateer First Assistant Attorney General Priscilla M. Hubenak Chief, Environmental Protection

Division Matthew B. Miller Assistant Attorney General Counsel of Record Craig J. Pritzlaff Assistant Attorney General OFFICE OF THE ATTORNEY GENERAL

OF TEXAS ENVIRONMENTAL PROTECTION

DIVISION P.O. Box 12548, MC-066 Austin, TX 78711-2548 (512) 463-2012 Counsel for the State of Texas

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 3 of 86

i

CERTIFICATE AS TO PARTIES, RULINGS & RELATED CASES

Pursuant to Circuit Rule 28(a)(1), Petitioners state as follows:

A. Parties, Intervenors, and Amici Curiae

These cases involve the following parties:

Petitioners:

No. 15-1385: Murray Energy Corporation.

No. 15-1392: State of Arizona; State of Arkansas; New Mexico

Environment Department; State of North Dakota; and State of

Oklahoma.

No. 15-1490: Sierra Club; Physicians for Social Responsibility;

National Parks Conservation Association; Appalachian Mountain Club;

and West Harlem Environmental Action, Inc.

No. 15-1491: Chamber of Commerce of the United States of

America; National Association of Manufacturers; American Petroleum

Institute; Utility Air Regulation Group; Portland Cement Association;

American Coke and Coal Chemicals Institute; Independent Petroleum

Association of America; National Oilseed Processors Association; and

American Fuel & Petrochemical Manufacturers.

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 4 of 86

ii

No. 15-1494: State of Texas; and Texas Commission on

Environmental Quality.

Respondents:

Respondents are the United States Environmental Protection

Agency (in No. 15-1385) and the United States Environmental

Protection Agency and Gina McCarthy, Administrator (in Nos. 15-1392,

15-1490, 15-1491, 15-1494).

Intervenors and Amici Curiae:

State of Wisconsin; Commonwealth of Kentucky; State of Utah;

and State of Louisiana are Petitioner-Intervenors†

American Lung Association; Natural Resources Defense Council;

Physicians for Social Responsibility; Sierra Club; Utility Air Regulatory

Group; National Association of Manufacturers; American Forest &

Paper Association; Chamber of Commerce of the United States of

America; American Chemistry Council; American Coke and Coal

Chemicals Institute; American Petroleum Institute; Independent

Petroleum Association of America; American Iron and Steel Institute;

† This Brief uses the term “State Petitioners” to refer collectively to the

Petitioners in Nos. 15-1392 and 15-1494 as well as the State

Intervenors.

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 5 of 86

iii

National Oilseed Processors Association; Portland Cement Association;

American Wood Council; American Fuel & Petrochemical

Manufacturers; and American Foundry Society are Respondent-

Intervenors.

American Thoracic Society is amici curiae in support of

Petitioners.

Institute for Policy Integrity at New York University School of

Law is amici curiae in support of Respondents.

B. Rulings Under Review

These consolidated cases involve final agency action of the United

States Environmental Protection Agency titled, “National Ambient Air

Quality Standards for Ozone,” and published on October 26, 2015, at 80

FR 65,292.

C. Related Cases

These consolidated cases have not previously been before this

Court or any other court. Counsel is aware of no other related cases.

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iv

TABLE OF CONTENTS

CERTIFICATE AS TO PARTIES, RULINGS & RELATED CASES........ i

TABLE OF AUTHORITIES ..................................................................... vi

GLOSSARY ............................................................................................xiii

JURISDICTIONAL STATEMENT ........................................................... 1

ISSUES PRESENTED .............................................................................. 2

STATUTES AND REGULATIONS .......................................................... 3

INTRODUCTION ...................................................................................... 4

STATEMENT OF THE CASE .................................................................. 5

STANDARD OF REVIEW....................................................................... 14

SUMMARY OF THE ARGUMENT ........................................................ 15

STANDING ............................................................................................. 19

ARGUMENT ........................................................................................... 19

I. EPA’s Approach to Background Ozone Levels Caused by

Uncontrollable Sources Violates the CAA. ............................................. 19

A. EPA Violated the CAA by Failing to Address Adequately

the Peak Effect of Uncontrollable Emissions on Peak Days. ........ 20

B. EPA Violated the CAA by Impermissibly Adopting a Non-

Textual Limitation on Its Own Authority. .................................... 28

C. EPA’s Promised Enforcement Relief Measures Are

Impractical and Misuse Portions of the CAA Intended for

Exceptional Rather than Routine Events. ..................................... 33

1. The Relief Mechanisms Identified by EPA Do Not

Adequately Address Uncontrollable Background Ozone. 34

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v

2. Where They Apply, the Relief Measures Are Inadequate

Solutions to the Problem of Uncontrollable Background

Ozone. ............................................................................... 41

II. Under EPA’s Construction of the Act, the NAAQS Review Process

Would Lack an “Intelligible Principle.” .................................................. 44

III. EPA’s Reliance on a Single Clinical Study to Justify the New

NAAQS Is Arbitrary and Capricious. ..................................................... 50

CONCLUSION ........................................................................................ 53

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vi

TABLE OF AUTHORITIES*

Page(s)

FEDERAL CASES

Allen v. Wright, 468 U.S. 737 (1984) ............................................................................. 19

Alliance for Cannabis Therapeutics v. DEA,

930 F.2d 936 (D.C. Cir. 1991) ............................................................. 30

* Am. Farm Bureau Fed’n v. EPA,

559 F.3d 512 (D.C. Cir. 2009) ........................................... 14, 16, 21, 27

Am. Trucking Ass’ns v. EPA

175 F.3d 1027 (D.C. Cir. 1999) ............................................... 29, 45, 46

* Am. Trucking Ass’ns v. EPA,

283 F.3d 355 (D.C. Cir. 2002) ........................................... 14, 30, 31, 46

American Petroleum Institute v. Costle,

665 F.2d 1176 (D.C. Cir. 1981) ......................................... 30, 31, 32, 33

Citizens to Preserve Overton Park, Inc. v. Volpe,

401 U.S. 402 (1971) ............................................................................. 43

Cronin v. Browner, 90 F. Supp. 2d 364 (S.D.N.Y. 2000) .................................................... 13

FDIC v. Meyer,

510 U.S. 471 (1994) ............................................................................. 48

Field v. Clark,

143 U.S. 649 (1892) ............................................................................. 44

Gregory v. Ashcroft, 501 U.S. 452 (1991) ............................................................................. 29

* Authorities on which Petitioners primarily rely are indicated with an

asterisk.

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vii

Home Box Office, Inc. v. FCC,

567 F.2d 9 (D.C. Cir. 1977) ..................................................... 16, 21, 27

J. W. Hampton, Jr. & Co. v. United States,

276 U.S. 394 (1928) ................................................................. 18, 44, 45

Lead Industries Association v. EPA,

647 F.2d 1130 (D.C. Cir. 1980) ..................................................... 31, 32

* Michigan v. EPA,

135 S. Ct. 2699 (2015) ................................................................ passim

Mississippi v. EPA,

744 F.3d 1334 (D.C. Cir. 2013) ................................................... passim

NLRB v. Brown,

380 U.S. 278 (1965) ............................................................................. 43

Sierra Club v. EPA,

No. 13-cv-2809 (N.D. Cal. Apr. 30, 2014) ........................................... 13

* Util. Air Regulatory Grp. v. EPA,

134 S. Ct. 2427 (2014) ............................................................ 14, 17, 29

West Virginia v. EPA,

362 F.3d 861 (D.C. Cir. 2004) ............................................................. 19

* Whitman v. American Trucking Associations,

531 U.S. 457 (2001) .................................................................... passim

CONSTITUTIONAL PROVISIONS

U.S. Const., Article I, § 1 ......................................................................... 44

FEDERAL STATUTES

5 U.S.C. § 706(2)(A) ................................................................................. 14

* 42 U.S.C. § 7407(a) .......................................................................... passim

42 U.S.C. § 7407(d) .................................................................................... 6

42 U.S.C. § 7408(a)(1) ................................................................................ 5

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viii

42 U.S.C. § 7408(a)(2) .......................................................................... 6, 18

42 U.S.C. § 7409(a)(2) ................................................................................ 6

42 U.S.C. § 7409(b)(1) .......................................................................... 5, 48

42. U.S.C. § 7409(b)(2) ............................................................................... 5

42 U.S.C. § 7409(d) .................................................................................. 45

42 U.S.C. § 7409(d)(1)...................................................................... 5, 6, 47

42 U.S.C. § 7409(d)(2)(A)-(B)..................................................................... 6

42 U.S.C. § 7410(a) .............................................................................. 7, 19

42 U.S.C. § 7410(c) .................................................................................... 7

42 U.S.C. § 7471 ........................................................................................ 7

42 U.S.C. § 7501-09a ............................................................................... 19

42 U.S.C. § 7509(b)(1) .............................................................................. 30

42 U.S.C. § 7509a(a) .......................................................................... 40, 42

42 U.S.C. § 7509a(b) .................................................................... 39, 41, 42

42 U.S.C. § 7511-15 ................................................................................. 19

42 U.S.C. § 7511a(a) .................................................................................. 7

42 U.S.C. § 7511a(a)(1) ............................................................................ 42

42 U.S.C. § 7511a(a)(2)(C) ....................................................................... 42

42 U.S.C. § 7511a(h) ................................................................................ 38

42 U.S.C. § 7511a(h)(1) ........................................................................... 41

42 U.S.C. § 7607(b) .................................................................................... 1

42 U.S.C. § 7607(d)(9)(A) ......................................................................... 14

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ix

42 U.S.C. § 7619(b)(1)(A) ......................................................................... 35

42 U.S.C. § 7619(b)(1)(A)(iii) ................................................................... 36

42 U.S.C. § 7619(b)(1)(B) ......................................................................... 36

42 U.S.C. § 7619(b)(2) .............................................................................. 35

REGULATIONS

40 C.F.R. § 50.14 ................................................................................. 3, 35

40 C.F.R. § 50.14(a)(1) ............................................................................. 35

40 C.F.R. § 50.14(c)(3)(iv)(C) ................................................................... 35

40 C.F.R. § 50.14(c)(3)(iv)(E) ................................................................... 35

40 C.F.R. § 50.19 ....................................................................................... 3

40 C.F.R. § 50.19(b) ....................................................................... 6, 21, 22

FEDERAL REGISTER

73 Fed. Reg. 16,436 (Mar. 27, 2008) ................................................. 11, 52

79 Fed. Reg. 75,242 (Dec. 17, 2014) .................................. 8, 37, 41, 43, 52

80 Fed. Reg. 65,292 (Oct. 26, 2015) ................................................. passim

80 Fed. Reg. 72,840 (Nov. 20, 2015) ........................................................ 37

OTHER AUTHORITIES

Ambient Standards Grp., U.S. Envtl. Prot. Agency, Policy Assessment for the Review of the Ozone National Ambient Air Quality Standards (2014) (“Policy Assessment”), Doc ID No.

EPA-HQ-OAR-2008-0699-0404 .............................................. 24, 25, 37

Dana R. Bennett, Nevada Mining Association, Comment Letter on

Proposed Rule, National Ambient Air Quality Standards for

Ozone (March 17, 2015), Doc. ID No. EPA-HQ-OAR-2008-0699-

3175 ............................................................................................... 36, 41

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x

Owen R. Cooper et al., Increasing Springtime Ozone Mixing Ratios in the Free Troposphere over Western North America,

463 Nature 344, 344-348 (2010), Doc. ID No. EPA-HQ-OAR-

2008-0699-4265 ............................................................................. 10, 36

Chris Emery et al., Regional and Global Modeling Estimates of Policy Relevant Background Ozone over the United States, 47

Atmospheric Env’t 206, 206–217 (2012), Doc. ID No. EPA-HQ-

OAR-2008-0699-4294 ...................................................................... 9, 23

EPA Opposition Br., No. 13-cv-2809 (N.D. Cal. Feb. 25, 2014) .............. 13

EPA’s Proposed National Ambient Air Quality Standards for Ozone: Hearing before the Subcomm. on Clean Air & Nuclear Safety of the S. Comm. on Env’t & Pub. Works, 113th Cong. 15-

16 (2014) (testimony of Ross Eisenberg, Vice President,

National Association of Manufacturers), cited at Doc. ID No.

EPA-HQ-OAR-2008-0699-3817 ............................................................ 8

Howard J. Feldman, American Petroleum Institute, Comments on

National Ambient Air Quality Standards for Ozone Proposed

Rule (March 17, 2015), Doc. ID No. EPA-HQ-OAR-2008-0699-

2465 ..................................................................................................... 12

Meiyun Lin et al., Transport of Asian Ozone Pollution into Surface Air over the Western United States in Spring, 117 J.

Geophysical Res. D00V07 (2012), Doc. ID No. EPA-HQ-OAR-

2008-0699-3148 ............................................................................. 9, 10

Meiyun Lin et al., Springtime High Surface Ozone Events over the Western United States: Quantifying the Role of Stratospheric Intrusions (“Lin Intrusions”), 117 J. Geophysical Res. D00V22

(2012), Doc. ID No. EPA-HQ-OAR-2008-0699-3148 ....... 10, 22, 25, 26

Eric C. Massey, Arizona Department of Environmental Quality,

Comment Letter on Proposed Rule, National Ambient Air

Quality Standards for Ozone (March 17, 2015), Doc. ID No.

EPA-HQ-OAR-2008-0699-3176 ............................................................ 8

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xi

Eric C. Massey, Western States Air Resources Council, Comment

Letter on Proposed Rule, National Ambient Air Quality

Standards for Ozone (March 16, 2015) (“Westar Comment”),

Doc. ID No. EPA-HQ-OAR-2008-0699-1990 ...................... 4, 21, 38, 39

Stephen F. Mueller & Jonathan W. Mallard, Contributions of Natural Emissions to Ozone and PM2.5 as Simulated by the Community Multiscale Air Quality (CMAQ) Model, 45 Envtl.

Sci. & Tech.4817, 4817-4823 (2011), cited in Doc. ID No. EPA-

HQ-OAR-2008-0699-0405 ............................................................. 10, 25

Edward S. Schelegle et al., 6.6-Hour Inhalation of Ozone Concentrations from 60 to 87 Parts per Billion in Healthy Humans, 180 Am. J. Respiratory & Critical Care Med. 265,

265-72 (2009), Doc. ID No. EPA-HQ-OAR-2008-0699-0198 .. 12, 51, 52

Sonoma Technologies, Regional and Local Contributions to Peak Local Ozone Concentrations in Six Western Cities (2006), cited

at Doc. ID No. EPA-HQ-OAR-2008-0699-1990 .................................. 23

Cathy Stepp, Wisconsin Department of Natural Resources,

Comments on EPA’s Proposed National Ambient Air Quality

Standards for Ozone (March 17, 2015), Doc. ID No. EPA-HQ-

OAR-2008-0699-1646 .......................................................................... 14

U.S. Envtl. Prot. Agency, Background Ozone Workshop,

https://www.epa.gov/sites/production/files/2016-

03/documents/2016workshopslides.pdf (“Workshop Slides”) ............. 40

U.S. Envtl. Prot. Agency, The National Ambient Air Quality Standards: Tools for Addressing Background Ozone,

https://www.epa.gov/sites/production/files/2015-

10/documents/20151001_background_ozone.pdf (“Tools Fact

Sheet”) ............................................................................................. 9, 19

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U.S. Envtl. Prot. Agency, Responses to Significant Comments on the 2014 Proposed Rule on the National Ambient Air Quality Standards for Ozone (2014), Doc. ID No. EPA-HQ-OAR-2008-

0699-4309 ...................................................................................... 40, 48

Charles-Edward A. Winslow, The Cost of Sickness and the Price of Health (1951) ...................................................................................... 49

Wyoming Department of Environmental Quality, Exceptional Events (Apr. 19, 2016, 2:00 PM),

deq.wyoming.gov/aqd/monitoring/resources/exceptional-events

(“Wyoming DEQ”) ............................................................................... 41

Lin Zhang et al., Improved Estimate of the Policy-Relevant Background in the United States Using the GEOS-Chem Global Model with 1/2° x 2/3° Horizontal Resolution over North America, 45 Atmospheric Env’t 6769, 6769-6776 (2011). Doc.

ID No. EPA-HQ-OAR-2008-0699-3148 .......................................... 9, 23

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GLOSSARY

Agency United States Environmental Protection Agency

CAA Clean Air Act

CASAC Clean Air Scientific Advisory Committee

EPA United States Environmental Protection Agency

FIP Federal Implementation Plan

FR Federal Register

NAAQS National Ambient Air Quality Standard

NASA National Aeronautics and Space Administration

NOAA National Oceanographic and Atmospheric Administration

O3 Ozone

ppb Parts Per Billion

SIP State Implementation Plan

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JURISDICTIONAL STATEMENT

This case challenges the following final rule promulgated by the

United States Environmental Protection Agency (EPA): “National

Ambient Air Quality Standards for Ozone,” 80 FR 65,292 (October 26,

2015)) (the “Rule”). Petitioners filed their Petitions for Review under 42

U.S.C. § 7607(b) within 60 days of the Rule’s publication in the Federal

Register, as required by the statute. This Court has jurisdiction

pursuant to that provision.

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ISSUES PRESENTED‡

1. Whether EPA violated the CAA by failing to address adequately

the peak effect of uncontrollable sources on peak days, thus

undermining States’ ability to meet their obligation for ensuring

that “national primary and secondary ambient air quality

standards will be achieved and maintained.” 42 U.S.C. § 7407(a).

2. Whether EPA’s construction of the Act fails to give meaning to the

“intelligible principle” needed to avoid an unconstitutional

delegation of legislative authority.

3. Whether EPA provided adequate scientific justification for a new

NAAQS.

‡ The Intervenor and Petitioner States also incorporate by reference the

Industry Petitioners’ argument that EPA has failed to provide a

reasoned explanation for changing the conclusions it draws from the

same basic scientific evidence considered in the prior NAAQS revision.

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STATUTES AND REGULATIONS

All applicable statutes are contained in the Brief for the Industry

Petitioners; the applicable regulations, 40 C.F.R. §§ 50.14, 50.19, appear

in the Addendum to this brief.

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INTRODUCTION

Sunland Park, NM, is a town of 15,000 people cornered between

the New Mexico-Texas border to the east and the United States’

international border with Mexico to the south. It has no major industry

and contributes just 3% of the precursor substances that form ozone in

the Paso del Norte airshed. Westar Comment at 19, (JA__). Its larger

neighbors—El Paso, TX and Juarez, Mexico—are close in proximity but

unreachable by the policies adopted in New Mexico, or (in the case of

Juarez) even Washington, DC. In fact, New Mexico is virtually

powerless to reduce the concentration of ozone around Sunland Park,

which arises overwhelmingly from sources beyond the State’s ability to

control. Moreover, because the area abuts El Paso, it does not qualify

for relief as a “rural transport area” under the Clean Air Act (CAA).

Nor can it escape the Act’s heavy regulatory burdens by pointing to

pollution generated in Juarez. Instead, through no fault of its own, the

State of New Mexico will now face heavy federal regulations and the

threat of punitive sanctions, including loss of highway funds, for failing

to do the impossible.

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The story of how Sunland Park’s attainment area became the

target of regulations that New Mexico has no hope of satisfying begins

with a legally flawed rule that fails to account for uncontrollable

sources of ozone. By imposing an unachievable standard, the Rule has

made it impossible for New Mexico and many other States to fulfill

their “responsibility” for ensuring that “national primary and secondary

ambient air quality standards will be achieved and maintained.” 42

U.S.C. § 7407(a). Any rule that ignores the States’ responsibility to

“achieve[] and maintain[]” the standard violates the CAA and must be

vacated.

STATEMENT OF THE CASE

A. The Clean Air Act and the NAAQS Program

The Clean Air Act requires EPA to issue and, at pentannual

intervals, review National Ambient Air Quality Standards (NAAQS) for

air pollutants that meet certain criteria. 42 U.S.C. §§ 7408(a)(1),

7409(d)(1). EPA must set primary NAAQS that are, “in the judgment of

the Administrator, . . . allowing an adequate margin of safety, []

requisite to protect the public health.” Id. § 7409(b)(1); see also id.

§ 7409(b)(2) (secondary NAAQS “requisite to protect public welfare”).

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“‘Requisite’ means the NAAQS must be sufficient, but not more than

necessary.” Mississippi v. EPA, 744 F.3d 1334, 1342 (D.C. Cir. 2013)

(internal quotation omitted).

Every five years, EPA must “complete a thorough review” of a

NAAQS and “make such revisions . . . as may be appropriate.” 42

U.S.C. § 7409(d)(1). That process involves consultation with the Clean

Air Scientific Advisory Committee (CASAC), id. § 7409(d)(2)(A)-(B), and

publication of “air quality criteria” explaining the “latest scientific

knowledge useful in indicating the kind and extent of all identifiable

effects on public health or welfare,” id. §§ 7408(a)(2), 7409(a)(2).

Once a NAAQS is set, EPA classifies each air quality control

region as “attainment,” “nonattainment,” or “unclassifiable.” 42 U.S.C.

§ 7407(d). For ozone, these classifications are based on the “3-year

average of the annual fourth-highest daily maximum 8-hour O3

concentration.” 40 C.F.R. § 50.19(b).

Each State has “primary responsibility” for ensuring that

“national primary and secondary ambient air quality standards will be

achieved and maintained.” 42 U.S.C. § 7407(a) (emphasis added). After

EPA sets or revises a NAAQS, the task then falls to the States to

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propose state implementation plans (SIPs) for the “implementation,

maintenance, and enforcement” of the new standard. Id. § 7410(a). If a

State fails to provide a SIP or if the Administrator disapproves it, EPA

may impose a federal implementation plan (FIP) of its own creation. Id.

§ 7410(c). Either way, nonattainment areas face a variety of

regulations, including a census of all ozone-causing emissions and

onerous permitting requirements for new sources. See, e.g., id. §

7511a(a) (listing requirements for “marginal” nonattainment areas).

Even for areas designated as in attainment, the SIP must “contain

emission limitations and such other measures as may be necessary . . .

to prevent significant deterioration of air quality.” Id. § 7471.

B. Background Ozone from Uncontrollable Sources

Ground-level ozone (O3) forms through the interaction of sunlight

with volatile organic compounds, mono-nitrogen oxides, and, over longer

periods, methane and carbon monoxide as well. 80 FR 65,299 (JA__).

These precursor compounds arise from various sources: human

activities within a State, which that State can control; human activities

outside a State, which that State cannot control; and natural sources

that no one can control. Id. Given the prevalence of uncontrollable

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sources of ozone and its precursors, ozone measurements “can be

substantially influenced by sources that cannot be addressed by

domestic control measures.” 80 FR 65,300 (JA__).

EPA itself recognizes that background ozone can be significant,

including “a non-de-minimis number” of locations where uncontrollable

ozone levels can “exceed the [former] NAAQS (i.e., 75ppb).” 79 FR

75,242 (JA__). According to NOAA, Las Vegas will “exceed EPA’s

proposed range of ozone NAAQS almost entirely due to background

ozone.” Eisenberg Testimony at 15-16 (JA__). Similarly, in Cochise

County, Arizona, EPA’s own models anticipate that uncontrollable

background ozone will account for 90.7% of the allowable 70ppb.

Massey Comment at 7, (JA__).

Even if background alone does not exceed the standard and force

an area into nonattainment, it can leave so little room for anthropogenic

ozone that attainment is functionally impossible. See, e.g., 79 FR

75,382 (JA__) (explaining that background levels can “prevent

attainment” where there are “few remaining opportunities for local

emission reductions”). Here, multiple studies show background levels

at or near the new standard of 70ppb. One study found that significant

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uncontrollable events could raise background ozone levels to 60–75 ppb.

Lin at 14, (JA__). Another recent study concluded that “[i]f the NAAQS

is lowered in the 60–70 ppbv range, areas of the intermountain West

will have little or no ability to reach compliance through North

American regulatory controls.” Zhang at 6774. Yet another study

found that background ozone could reach levels of 60–70ppb. Emery

206-17, (JA__).

The issue of background ozone is particularly acute when dealing

with peak effects of uncontrollable emissions on peak ozone days.

Although some background sources are relatively constant producers,

other sources are highly volatile and can produce significant spikes in

ozone and its precursors. “Stratospheric intrusions,” for example—in

which upper-atmosphere ozone descends to the surface, usually in

connection with warm weather and high altitude—can dramatically

increase ozone levels through no fault of the States or their industries.

See Tools Fact Sheet at 4 (JA__). A recent study funded by NOAA

found over a dozen intrusions during just three months, contributing as

much as 20-40ppb to background ozone, and pushing eight-hour ozone

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readings above the new NAAQS, sometimes as high as 86ppb. Lin

Intrusions at 17, (JA__).

Similarly, transport from foreign industry increases ground-level

ozone and can cause spikes in ozone under certain conditions. As

foreign industry has expanded, the United States has seen a

corresponding increase in the share of its background ozone

attributable to foreign sources. Cooper 344-48 (JA__) (“[T]ransported

ozone pollution from Asia . . . is increasing by approximately 0.63ppb

per year.”). One modeling study found that 49% of springtime ozone

readings above 70ppb in the southwestern United States “would not

have occurred” without Asian emissions. Lin at 14 (JA__).

Wildfires and lightning also cause sudden increases in ozone

levels. One modeling study found that lightning can add as much as 25-

30ppb and wildfires can add more than 50ppb. Mueller & Mallard

4817-23 (JA__).

C. Recent NAAQS Revisions.

The Industry Petitioners have provided an extensive summary of

the recent NAAQS revisions, which reduce the primary and secondary

standards to 70ppb. Indus. Pets. Br. 7-16. In particular, the Industry

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Petitioners have traced the gradual ratcheting down of the ozone

NAAQS—beginning at 120ppb, proceeding to 80, then 75, and now

70ppb—to the point that the current standard is colliding with

background levels in many parts of the country.

The Petitioner States adopt that summary but highlight several

features of the key clinical study on which EPA relies. Unlike

epidemiological studies that attempt to estimate the effects of ozone by

studying respiratory illnesses in the general population, clinical studies

control for the many other components of the atmosphere and isolate

subjects’ responses to an increase in ozone. The availability of new

clinical evidence was central to this Court’s affirmance of the 2008

NAAQS revision. Mississippi, 744 F.3d at 1343-44; see also id. at 1351

(“‘[T]he epidemiological studies are not themselves direct evidence of a

causal link between exposure to O3 and the occurrence of health

effects.’” (quoting 73 FR 16,479)); see also 80 FR 65,323 (JA__)

(epidemiological evidence of health effects is “complicated by the

presence of co-occurring pollutants or pollutant mixtures”).

In 2008, EPA had before it a pair of clinical studies in which 30

participants were exposed to ozone concentrations of 60 and 80ppb.

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Mississippi, 744 F.3d at 1349-50. At the lower concentration, just six of

the participants experienced lung-function decrements of at least 10%.

Id. at 1349-50. EPA concluded that this minor deviation from normal

lung function did not justify lowering the NAAQS to 60ppb and instead

settled on 75ppb as the level requisite to protect public health. Id.

The current rulemaking cites two clinical studies and relies

almost exclusively on one of them. Schelegle 265-72 (JA__). That study

exposed 31 participants to over six hours of near-continuous activity in

an environment of 72ppb ozone. It found that six of the 31

participants—almost exactly the same ratio that proved unpersuasive

in 2008—reported (reversible) decrements of at least 10%. Id. at 269

(JA__); Feldman Comment at 4 (JA__). Even by EPA’s definition,

decrements alone do not constitute an “adverse health effect.” They

must appear “in combination with” respiratory symptoms. 80 FR

65,330 (JA__). Although the study found some evidence of both

respiratory symptoms and reduced lung function, they were

uncorrelated across study participants. Id.; Feldman Comment at 4

(JA__). EPA identified no other clinical evidence to support the

existence of any harm to public health at levels below 80ppb.

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In light of the paucity of new evidence, EPA took years to

announce its latest revision to the standard. Seeking to compel the

Agency to complete its rulemaking, several environmental

organizations filed suit in the Northern District of California. Sierra

Club v. EPA, No. 13-cv-2809 (N.D. Cal. Apr. 30, 2014). In its brief

opposing the plaintiffs’ timeline, EPA argued that “‘[t]he public has a

significant interest in ensuring that the government does not

promulgate rules via a process that emphasizes expediency over quality

and accuracy.’” EPA Opposition Br., No. 13-cv-2809, at 11-12 (N.D. Cal.

Feb. 25, 2014) (quoting Cronin v. Browner, 90 F. Supp. 2d 364, 373

(S.D.N.Y. 2000)). The Agency countered the plaintiffs’ arguments for

feasibility, stating that “[i]t is difficult to imagine a circumstance where

an agency could not sign some sort of a flawed rule by any particular

date; but promulgating a flawed rule does nothing to advance the goals

of Congress.” Id. at 12. On April 30, 2014, the court ordered EPA to act

on precisely the timeline plaintiffs requested, and EPA did just that.

Finally, the Petitioner States add that the Rule irrationally

lengthens ozone monitoring seasons for several States based upon ozone

readings above 60ppb between 2010 and 2013. 80 FR 65,416 (JA__).

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The Agency took this approach even for States that demonstrated that

they never had a single reading above 70ppb in the last twenty years

over the majority of the new monitoring period. Stepp Comment at 3-5

(JA__).

STANDARD OF REVIEW

An agency rule must be set aside if it is “arbitrary, capricious, an

abuse of discretion, or otherwise not in accordance with law.” 42 U.S.C.

§ 7607(d)(9)(A); accord 5 U.S.C. § 706(2)(A). While this Court considers

challenges to NAAQS under the “same highly deferential standard of

review that we use under the Administrative Procedure Act,” such

challenges receive “a searching and careful inquiry into the underlying

facts.” Am. Trucking Ass’ns v. EPA, 283 F.3d 355, 362 (D.C. Cir. 2002)

(quotation omitted).

Moreover, “[a]n agency’s failure adequately to consider a relevant

and significant aspect of a problem may render its rulemaking arbitrary

and capricious.” Am. Farm Bureau Fed’n v. EPA, 559 F.3d 512, 520

(D.C. Cir. 2009). In addition, “an agency interpretation that is

inconsistent with the design and structure of the statute as a whole

does not merit deference.” Util. Air Regulatory Grp. v. EPA, 134 S. Ct.

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2427, 2442 (2014) (citation omitted). EPA, in particular, violates the

CAA if it wrongly considers itself bound not to consider “relevant

factors.” Michigan v. EPA, 135 S. Ct. 2699, 2706 (2015).

SUMMARY OF THE ARGUMENT

I. The Rule must be vacated because the Agency’s approach to

the critical issue of background ozone violates the CAA.

A. Under the CAA, States have the “primary responsibility” for

ensuring that “national primary and secondary ambient air quality

standards will be achieved and maintained.” 42 U.S.C. § 7407(a)

(emphasis added). EPA’s failure to address adequately the indisputably

relevant issue of the States’ ability to “achieve[]” the new NAAQS, and

concomitant failure to provide an adequate response to significant

public comments on this issue, is reason enough to vacate the Rule.

Numerous commenters presented EPA with studies

demonstrating that the peak effects of sources that the States cannot

control, on peak days, will make compliance with the new standard

unduly onerous, and sometimes impossible. Indeed, EPA’s own

modeling illustrates the same problem. Yet, the Agency did not take

account of this critical issue, instead choosing to focus on “average” and

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“seasonal mean” impacts of uncontrollable sources. 80 FR 65,328

(JA__). This focus is unresponsive because nonattainment does not

depend on averages, but instead requires just four exceedances per

year.

EPA’s analysis thus fails the basic requirement that an agency

must address “significant aspect[s] of a problem,” Am. Farm Bureau,

559 F.3d at 520, and respond to all “significant” comments on this issue,

Home Box Office, Inc. v. FCC, 567 F.2d 9, 35 & n.58 (D.C. Cir. 1977).

The peak effects of uncontrollable sources on peak days will lead the

Agency to impose burdensome pollution-control measures in areas

where such measures have no potential to improve air quality or serve

public health. This is the paramount problem with regard to the critical

issue of background ozone, and EPA’s failure to address the problem

requires that the Rule be vacated.

B. EPA also violated the CAA by unlawfully limiting its

consideration of the impact of background ozone from uncontrollable

sources. See Michigan, 135 S. Ct. at 2706. The Agency took the

position that it may only consider ozone from uncontrollable sources in

selecting a standard from within a “range of values” that EPA has

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already deemed “reasonable.” 80 FR 65,328 (JA__). This is contrary to

the text of the CAA, which requires EPA to set NAAQS such that States

can fulfill their “responsibility” that the standard be “achieved and

maintained.” 42 U.S.C. § 7407(a). Since States have no legal or

practical ability to control ozone from uncontrollable sources, EPA has a

duty to consider fully such sources in setting the standard. EPA’s

contrary position would permit (and perhaps require) the Agency to set

standards that cannot be “achieved and maintained” by the States.

This result is not only contrary to the text of the CAA, but would

transform the NAAQS program in violation of the bedrock

administrative law principle that an agency’s interpretation is unlawful

if it is “inconsisten[t] with the design and structure of the statute as a

whole.” UARG, 134 S. Ct. at 2442.

C. Relying on the CAA’s provisions for enforcement-stage relief

is no response to these defects. Provisions addressing “exceptional

events” are ill-suited to addressing routine exceedances that will

inevitably occur due to uncontrollable background ozone. Likewise, the

Act’s limited measures for helping areas affected by rural transport and

international pollution are intended for infrequent exceedances, as

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demonstrated by the assumption that these areas should remain

classified as nonattainment and subject to the corresponding burdens.

More fundamentally, enforcement-stage relief measures require States

to file onerous petitions with EPA, which the Agency may decline in its

discretion.

II. EPA’s construction of the CAA misapplies Whitman v.

American Trucking Associations, 531 U.S. 457 (2001), to eschew any

consideration that would halt the NAAQS for a “zero-threshold”

pollutant at a level greater than zero. The Act offers several such

“intelligible principles” to guide the Agency’s work. J. W. Hampton, Jr.

& Co. v. United States, 276 U.S. 394, 409 (1928). Its references to

“achieve[] and maintain[],” “requisite,” “appropriate,” and “public

health” all indicate that EPA must consider the burden of a NAAQS

that is unprecedentedly close to background levels.

III. Finally, EPA failed to explain how the “latest scientific

knowledge . . . on public health or welfare” justifies the new NAAQS. 42

U.S.C. § 7408(a)(2). This failure is apparent in the Agency’s excessive

reliance on a single clinical study with significant limitations.

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STANDING

The Petitioner States have standing to challenge a Rule that

requires them to revise their SIPs to comport with the new standard.

42 U.S.C. § 7410(a); see West Virginia v. EPA, 362 F.3d 861, 868 (D.C.

Cir. 2004). EPA’s new standard also threatens to bring additional areas

within the Petitioner States into nonattainment, which imposes an

assortment of burdens. 42 U.S.C. §§ 7501-09a, 7511-15. As a result,

the Petitioner States suffer an actual injury that is “fairly traceable” to

the revised NAAQS and is likely to be redressed by a favorable decision.

Allen v. Wright, 468 U.S. 737, 751 (1984).

ARGUMENT

I. EPA’s Approach to Background Ozone Levels Caused by

Uncontrollable Sources Violates the CAA.

The CAA provides that each State has “primary responsibility” for

ensuring that “national primary and secondary ambient air quality

standards will be achieved and maintained.” 42 U.S.C. § 7407(a)

(emphasis added). As EPA has conceded, in carrying out this statutory

duty, “states are not responsible for reducing emissions from

background sources.” Tools Fact Sheet at 1 (JA__). In the Rule, EPA

attempted to retreat partially from this necessary concession, arguing

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that achievability is relevant to choosing a NAAQS level “within the

range of reasonable values” that the Administrator identified, but

forbidden when setting the “reasonable” range in the first place. 80 FR

65,328 (JA__). The Agency thereafter ignored this textually-

indefensible distinction and sought to explain away the problem of

uncontrollable ozone through a series of non sequitur arguments.

There are two approaches that this Court could take to finding

that EPA acted unlawfully in addressing the critical issue of

background ozone from uncontrollable sources. The narrower approach

is to declare that the Rule is unlawful because the Agency conceded that

the “states are not responsible for reducing emissions from background

sources,” see infra Part I.A, and then failed to explain adequately how

the Rule’s new standard is consistent with that textually-mandated

principle. Alternatively, and more broadly, this Court could definitively

hold that EPA violated the CAA by casting aside concerns regarding

“achiev[ability]” and vacate the Rule on that basis. See infra Part I.B.

A. EPA Violated the CAA by Failing to Address Adequately the

Peak Effect of Uncontrollable Emissions on Peak Days.

1. EPA has conceded that even under its own modeling,

uncontrollable sources of ozone can make it harder—and, sometimes,

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impossible—for States to attain EPA’s new NAAQS standard. 80 FR

65,436 (JA__). Because EPA has acknowledged that the impact of

uncontrollable ozone is a relevant, significant consideration for

purposes of this rulemaking, the Agency was duty-bound to address

rationally all “significant aspect[s] of [this] problem,” Am. Farm

Bureau, 559 F.3d at 520; State Farm, 463 U.S. at 43, and to respond to

all “significant” comments on this issue, Home Box Office, 567 F.2d at

35 & n.58.

Numerous commenters addressed the background ozone issue,

raising the critical point that peak impacts from uncontrollable sources

on days with peak ozone measurements make it difficult or impossible

for States to “achieve,” 42 U.S.C. § 7407(a), the new NAAQS standard

(the “peak/peak problem”). See, e.g., Westar Comment at 6, (JA__)

(noting the “significant difference” between average data and “actual

exceedances of the standard, which EPA acknowledges is more relevant

from a regulatory standpoint”).

The process for NAAQS nonattainment designations illustrates

why EPA’s failure to address adequately the peak/peak problem is so

consequential. 40 C.F.R. § 50.19(b). Every day during the monitoring

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season, each site determines which eight-hour period has the highest

average ozone reading, which then becomes the daily value. Id. Each

area then determines the fourth-highest daily value in a given year. Id.

Every year, the fourth-highest readings from the past three years are

averaged to determine that year’s “design value,” which is compared to

the NAAQS. Id. This process means that if uncontrollable sources

cause high ozone readings even a few days per year, those infrequent

peak readings will be sufficient to push an area out of attainment. The

process thus magnifies—sometimes to the point of crowding out all

other evidence—the peak effects of uncontrollable sources on peak days.

2. The administrative record unambiguously demonstrates that

uncontrollable sources, at their peak, will make it difficult, and

sometimes impossible, for States to meet EPA’s new NAAQS on peak

ozone days.

Multiple studies in the record demonstrate that uncontrollable

sources will leave little to no room for U.S. manmade emissions at the

new 70ppb NAAQS standard. One study, jointly funded by NOAA and

NASA, found over a dozen instances in which ozone from stratospheric

intrusions raised background levels to 60–75 ppb. Lin Intrusions

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(JA__). Another study estimated that the annual fourth-highest

background ozone levels in the intermountain west are 50–60ppb. See

Zhang 6769, 6770 (JA__). This study concluded that “if the NAAQS is

lowered in the 60–70 ppb range, areas of the intermountain West will

have little or no ability to reach compliance through North American

regulatory controls.” JA__. A different study modeled background

ozone and found that it could reach levels of 60–70 ppb. Emery 206,

216 (JA__). And another estimated that “background ozone

concentrations . . . ranged from 47ppb to 68ppb at six western cities

during ozone episodes.” Sonoma Technologies at 3-1 (JA__).

Notably, many of these studies systematically underestimate the

peak effects of uncontrollable sources of ozone on peak days because

their models do not account for highly volatile events that can

significantly impact ozone—such as wildfires, lightning, stratospheric

intrusions, and unique meteorological conditions. See Zhang 6769,

6770 (JA__).

EPA’s own modeling confirms the widespread nature of this

peak/peak problem. Specifically, EPA’s model identified a substantial

number of days where uncontrollable sources are at, near, or above the

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70ppb standard, and where uncontrollable source effects are also at

peak levels.

Policy Assessment at 2A-25 (JA__) (internal box added).1 While EPA

sought to downplay its model’s results as “infrequent events,” 80 FR

65,328 (JA__), EPA has no answer for the critical point that just a few

high readings per year trigger a finding of nonattainment.2

1 Each dot in the red box represents at least one day where ozone

exceeded 70ppb and where background ozone would have been at least

60ppb without any U.S. manmade emissions.

2 EPA also pointed to an alternative model (dubbed the “source

apportionment” model), Policy Assessment at 2-14, which predicts

fewer—although still some—exceedances resulting from uncontrollable

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In addition, while EPA’s own modeling confirms the prevalence of

the peak/peak problem, the Agency’s reasoning undercounts that

problem in significant respects. As EPA concedes, its model “was not

expressly developed to capture” events such as wildfires, lightning,

stratospheric intrusions, and unique meteorological conditions, Policy

Assessment at 2A-42 (JA__), even though EPA acknowledges that “the

highest background episodic concentrations are typically associated

with [these types of events],” Id. at 2A-14. For example, although EPA

modeled wildfire emissions, the Agency admits that its model accounts

only for “monthly‐average wildfire emissions which are not intended to

capture discrete events.” Id. at 2A-8-9. And there is no indication that

EPA’s model included any input for stratospheric intrusions, despite

studies showing that these events can cause spikes as large as 40ppb.

Lin Intrusions at 17 (JA__). Likewise, wildfires can add over 50ppb,

Mueller & Mallard 4817-23 (JA__), lightning can add 30ppb, and unique

meteorological conditions can cause Asian emissions to add up to 15ppb,

ozone. This alternative significantly underestimates the peak effects of

uncontrollable sources by classifying all ozone that is created by a

combination of precursors emitted from both uncontrollable and

controllable sources as controllable ozone. Id. at 2-16.

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Lin Intrusions at 10 (JA__), beyond what they already contribute on an

“average” day.

3. EPA’s primary response to this overwhelming record evidence

demonstrating the peak/peak problem for the new 70ppb standard is to

change the subject, focusing on the average effects of uncontrollable

sources. For example, the Agency reports “seasonal mean” background

levels of only 25-50ppb. 80 FR 65,328 (JA__); see also id. (attempting a

similar sleight of hand for background levels on high-ozone days by

“average[ing] over the entire U.S.”). But as explained above, States’

“responsibility” for ensuring that the new NAAQS “will be achieved and

maintained,” 42 U.S.C. § 7407(a), flows from peak impacts—not

averages. If the Agency’s attainment designations were based on

seasonal-average ozone readings, then seasonal-average background

concentrations would be relevant. As it stands, however, NAAQS

designations depend on an area’s four worst days.

It is disingenuous for EPA to cite average figures when

promulgating a new NAAQS only to use specific 8-hour data when

determining nonattainment. The legal ramification of this legerdemain

is that the Agency has not addressed a “significant aspect of [the]

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problem,” Am. Farm Bureau, 559 F.3d at 520, which arises not from

averages, but from the peak effects of uncontrollable ozone on the

relatively few days that determine an area’s design value.

As a fallback to its “seasonal mean” response, the rulemaking

briefly discusses the “average” effect of uncontrollable ozone sources on

peak days. 80 FR 65,328 (JA__). This is not responsive to the problem

commenters raised. The issue is not the average effect of uncontrollable

sources of ozone on either average- or high-ozone days. Rather, the

problem is peak effects of uncontrollable sources on peak ozone days.

Given how NAAQS compliance is measured, these events are

sufficiently common to make it difficult, or even impossible, for States

to fulfill their “responsibility” for ensuring that the new 70ppb standard

“will be achieved and maintained,” 42 U.S.C. § 7407(a). EPA provided

no adequate answer for this significant problem, Am. Farm Bureau, 559

F.3d at 520, and failed to respond to “substantial” comments raising

that issue, Home Box Office, 567 F.2d at 35 & n.58. The Rule is thus

unlawful on this basis alone.

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B. EPA Violated the CAA by Impermissibly Adopting a Non-

Textual Limitation on Its Own Authority.

The Agency also acted unlawfully because it narrowed its

consideration of the critical issue of the new standard’s “achiev[ability]”

in a manner unsupported by statutory text. 42 U.S.C. § 7407(a). In the

Rule, EPA concluded that background ozone was relevant only to

selecting the NAAQS level “within the range of reasonable values” the

Administrator had already identified, but that background could not

inform the selection of the “reasonable” range. 80 FR 65,328 (JA__).

EPA thus recognizes that achievability is relevant but, without

statutory justification, treats it as selectively relevant. The Agency’s

non-textual narrowing of the NAAQS analysis violates the CAA. See

Michigan, 135 S. Ct. at 2606-07 (EPA’s erroneous conclusion that a

mandatory factor is “irrelevant” to a regulatory decision renders the

rule unlawful).

EPA’s claim that it had to consider background ozone only when

selecting the NAAQS standard from “within the range of reasonable

values” is unauthorized. As noted above, the CAA assigns to States the

“primary responsibility” for ensuring that “national primary and

secondary ambient air quality standards will be achieved and

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maintained.” 42 U.S.C. § 7407(a). EPA’s reading of the CAA as making

“achiev[ability]” relevant only for selecting the NAAQS standard from

“within a range of reasonable values,” 80 FR 65,328 (JA__), is

irreconcilable with this statutory text. Put another way, nothing in the

statute’s expectation of “achiev[ability]” suggests that the concept

should be ignored entirely in determining a “reasonable range,” but

then reemerge when selecting from within that range. EPA’s error here

is remarkably similar to the violation that the Supreme Court recently

found fatal in Michigan. In that case, just as here, EPA ignored a

mandatory consideration (there, costs; here, achievability) at the first

step of its regulatory analysis, but said that it could consider the factor

at a later step. See 135 S. Ct. at 2710-11.

EPA’s position is also “inconsisten[t] with the design and structure

of the statute as a whole,” UARG, 134 S. Ct. at 2442 (quotation

omitted), and raises serious federalism concerns, Gregory v. Ashcroft,

501 U.S. 452, 460-61 (1991). Under EPA’s interpretation, if the

Administrator selected a range that no State could meet “without action

affirmatively extracting chemicals from nature,” Am. Trucking Ass’ns v.

EPA (“ATA I”), 175 F.3d 1027, 1036 (D.C. Cir. 1999), opinion modified

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on reh’g, 195 F.3d 4, aff'd in part, rev’d in part by Whitman, the Agency

would be duty-bound to impose upon States a standard within that

impossible range. States, having no ability to “achieve” the impossible,

would then be subject to severe sanctions under the CAA, including loss

of highway funds. 42 U.S.C. § 7509(b)(1). It is hornbook administrative

law that “[i]mpossible requirements imposed by an agency are perforce

unreasonable.” Alliance for Cannabis Therapeutics v. DEA, 930 F.2d

936, 940 (D.C. Cir. 1991). EPA’s claim that Congress instructed the

Agency to require the impossible here—especially in a context that

carries severe punishments for noncompliance—is not credible.

In the Rule, EPA rested its argument on certain statements in

American Trucking and American Petroleum Institute v. Costle, 665

F.2d 1176 (D.C. Cir. 1981). 80 FR 65,328 (JA__). These cases do not

support the Agency’s position.

First, in American Trucking, EPA had set the ozone NAAQS at

80ppb, in part because a 70ppb standard would be “too close to peak

background levels.” 283 F.3d at 379. This Court rejected a challenge to

the Agency’s reliance on the peak impacts of uncontrollable sources,

explaining: “although relative proximity to peak background ozone

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concentrations did not, in itself, necessitate a level of [80ppb], EPA

could consider that factor when choosing among the three alternative

levels.” Id. In the present case, the Agency inexplicably engrafted the

word “only” into this holding, entirely changing the statement’s

meaning: “[C]ourts have clarified that EPA may consider proximity to

background concentrations . . . only in the context of considering

standard levels within the [pre-determined] range.” 80 FR 65,328

(JA__) (citing Am. Trucking, 283 F.3d at 379) (emphasis added). But

American Trucking never held that selecting a standard from within a

“range” is the only situation in which EPA can consider proximity to

background ozone concentrations, and the Agency’s attempt to suggest

otherwise is incorrect.

Second, this Court’s statement in American Petroleum that EPA

“may not consider economic and technological feasibility in setting air

quality standards,” and later reiteration of the same point, similarly

does not support the Agency’s position. 665 F.2d at 1185 (quoting Lead

Industries Association v. EPA, 647 F.2d 1130 (D.C. Cir. 1980)).

American Petroleum first made this statement while responding to the

specific argument raised by the American Petroleum Institute (API)

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that the “costs of meeting [the new NAAQS]” were too high. Id. at 1184.

As the Supreme Court explained in Whitman, 531 U.S. at 464,

American Petroleum was merely one of several cases from this Court

following the rule from Lead Industries that “economic considerations

may play no part in the promulgation of ambient air quality standards.”

When American Petroleum turned to the city of Houston’s

objections that the new standard would be “impossible” for the city to

meet because of “natural factors,” this Court noted that its prior

response to API’s cost argument addressed this objection “in part.” 665

F.2d at 1185 (emphasis added). Another “part” of this Court’s answer to

Houston’s argument, however, was that the Agency need not “tailor

national regulations to fit each region or locale.” Id.

The issue in the present case is entirely different. American

Petroleum involved a single city asserting that it would not be able to

meet the new standard, based primarily on concerns regarding the

availability of emission-control technology. In the present case, the

States argue that the new standard will make it extremely difficult, and

sometimes impossible, for many of them to satisfy their statutory

responsibility for ensuring that NAAQS “will be achieved and

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maintained.” 42 U.S.C. § 7407(a). Given that the CAA imposed no such

duty on the city of Houston, this Court’s rejection of the city’s

arguments does not address the issues of statutory authority and

achievability the States raise here. American Petroleum is also

factually distinguishable because the current NAAQS is closer to the

level of ozone from uncontrollable sources, and the role of foreign-

generated pollution has mushroomed during the intervening 35 years.

C. EPA’s Promised Enforcement Relief Measures Are

Impractical and Misuse Portions of the CAA Intended for

Exceptional Rather than Routine Events.

Tacitly acknowledging that it would be unlawful to hold States

responsible for ozone levels that they cannot control, the Rule suggests

that the States may qualify for limited relief at the enforcement stage.

80 FR 65,436 (JA__). The tools EPA has in mind, however, are limited

in their applicability and, even where applicable, do not undo the

burdens created by the new standard.3 Promulgating a rule that

depends on enforcement relief is problematic in its own right, but that

3 Of course, even if they were completely effective at responding to

nonattainment resulting from uncontrollable background ozone, these

mechanisms do not relieve EPA of its responsibility to engage in

“reasoned decisionmaking” that addresses “all relevant factors.”

Michigan, 135 S. Ct. at 2706; see supra Part I.A.

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strategy becomes a basis for vacatur when the promised relief is

illusory.

1. The Relief Mechanisms Identified by EPA Do Not

Adequately Address Uncontrollable Background Ozone.

EPA identifies three measures that it promises will provide relief

for areas where background ozone levels approach or exceed the revised

NAAQS: (1) areas that would be classified as nonattainment under the

70ppb standard due only to exceptional events could avoid that

designation “through exclusion of data affected by [those] exceptional

events;” (2) nonattainment areas that qualify as “rural transport areas”

could avoid certain more stringent requirements applicable to higher

classifications of nonattainment areas; and (3) nonattainment areas

that qualify for the international transport provisions could escape their

obligation “to demonstrate attainment” and to adopt “more than

reasonable controls” on local stationary sources. 80 FR 65,436 (JA__).

Behind all three of these measures are provisions of the CAA.

Unsurprisingly, none of them creates an exception so malleable that it

can allow an area to demonstrate compliance with a standard that is set

at, near, or below background levels.

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First, the CAA’s “exceptional events” provision tasks the

Administrator with promulgating “regulations governing the review

and handling of air quality monitoring data influenced by exceptional

events.” 42 U.S.C. § 7619(b)(2). It defines an “exceptional event” as one

that “is not reasonably controllable or preventable” and “is caused by

human activity that is unlikely to recur at a particular location or a

natural event.” Id. § 7619(b)(1)(A).

In 2007, EPA announced a rule for excluding data based on the

occurrence of an exceptional event. 40 C.F.R. § 50.14. The threshold is

high. A State must show that a specific event “caused a specific air

pollution concentration at a particular air quality monitoring location”

and must establish “a clear causal relationship” between the event and

the air-quality measurement at issue. 40 C.F.R. §§ 50.14(a)(1),

(c)(3)(iv)(E). Moreover, the rule provides that an exceptional event

cannot reflect “normal historical fluctuations, including background.”

Id. § 50.14(c)(3)(iv)(C) (emphasis added). EPA also notes in the

preamble to the revised NAAQS that exceptional events do not include

“routine natural emissions from vegetation, microbes, animals, and

lightning.” 80 FR 65,439 n.239 (JA__).

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The reason the “exceptional events” provision does not encompass

biological, meteorological and recurring anthropogenic events is that

they are not exceptional, precisely because they are part of background

conditions. As Harvard’s Daniel Jacob explains regarding a NAAQS of

70ppb, “[y]ou’re not talking about events anymore. You’re talking about

the routine. . . . And at that point, I think the system is going to break.”

Bennett Comment at 15 (JA__). The Act’s exclusion of truly exceptional

events only underscores EPA’s failure to consider routine obstacles to

achievability, in setting the NAAQS.

Moreover, the exceptional events provision does not allow an area

to exclude anthropogenic foreign emissions because it applies only to

“an event caused by human activity that is unlikely to recur.” 42 U.S.C.

§ 7619(b)(1)(A)(iii) (emphasis added). As recognized by all parties,

international transport is very likely to recur, and with increasing

intensity. Cooper 344, 344-48 (JA__). The provision also excludes

“stagnation of air masses,” “meteorological inversions,” and other

meteorological events “involving high temperatures or lack of

precipitation.” 42 U.S.C. § 7619(b)(1)(B).

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EPA has recently proposed a revision to the exceptional events

rule. 80 FR 72,840 (Nov. 20, 2015). Even if EPA finalizes a revised

rule, regulations and new agency guidance cannot alter the statutory

criteria.4 Chief among these are the CAA’s exclusion of recurring

human-caused events and meteorological events that EPA recognizes

are “the cause” of increased exceedances. Policy Assessment at 2-3 to 2-

4. The only time EPA may consider these factors is in setting the

NAAQS itself. At best, EPA peddles false hope in suggesting that it has

the latitude to address background ozone through exceptional events

regulations. At worst, the Agency has strategically refused to consider

the impossibility of achieving its NAAQS rule while pointing to future

enforcement-stage relief, only to claim later that its hands are tied by

the statute.

4 EPA promulgated the NAAQS before making revisions to its

exceptional events rule. But States are already at work designating

nonattainment areas in order to meet an October 1, 2016 deadline. 79

FR 75,354 (JA__). As a result, the subsequent issuance of a revised rule

is of little benefit, a fact compounded by the proposed rule’s failure to

address uncontrollable background ozone. For example, the revised

rule would still exclude biological processes and lightning, as well as

foreign anthropogenic emissions.

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Second, the CAA’s provisions for rural transport areas fail to

provide effective relief for nonattainment due to background. To begin

with, designation as a rural transport area simply moves the area from

one class of nonattainment to another, 42 U.S.C. § 7511a(h); it does not

avoid the requirements applicable to all nonattainment areas. See infra

Part II.B.

Even that minor accommodation excludes huge swaths of the

country. Under the statute, a rural transport area cannot contain

sources that make a “significant contribution” to ozone concentrations

and cannot include or be adjacent to a Metropolitan Statistical Area

(“MSA”). 42 U.S.C. § 7511a(h). When applied to large counties in the

West, these criteria render the rural transport provision a nullity.

White Pine County, Nevada, for example, covers 9,000 square miles and

has a tiny population of just 10,000 inhabitants. It nevertheless cannot

qualify as a rural transport area because it is adjacent to the Salt Lake

City MSA, which is itself approximately the size of New Jersey. Westar

Comment at 15 (JA__). In fact, due to the size of western counties, the

Salt Lake City MSA has the potential to disqualify 46,023 square

miles—an area the size of Pennsylvania—from being classified as rural

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transport areas. Similar disqualifications occur around Phoenix, Las

Vegas, Denver, and El Paso. In Cochise County, Arizona, which cannot

benefit from the rural transport rule because of its proximity to Tucson,

EPA estimates that background ozone contributes 92% of that county’s

design value. Westar Comment at 7 (JA__). The unlucky

correspondence of large counties and high background ozone levels in

western States means that the CAA’s rural transport provision is

ineffective medicine to cure a NAAQS set at or near background levels.

Third, the CAA’s international transport provisions authorize

limited relief for nonattainment areas that can establish “to the

satisfaction of the Administrator” that they would have met the NAAQS

“but for emissions emanating from outside of the United States.” 42

U.S.C. § 7509a(b). Even where applicable, these provisions do not allow

a State to avoid a nonattainment designation or even to obtain a lower

nonattainment classification, see 80 FR 65,444 (JA__); they simply

provide exemptions from a handful of nonattainment requirements.

See infra Part II.B.

Relief under these provisions is further illusory because they

require the States to establish that international transport is the “but

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for” cause of nonattainment. The issue of which party bears the burden

is important because quantifying the amount of pollution carried from

outside the United States is difficult. See Response to Comments at

343 (JA__) (“there is no way to definitively measure or validate these

numbers”); Workshop Slides at 21 (JA__) (using a “surrogate” for

internationally transported ozone to identify a wide range—between 0.1

and 0.7 ppb/year—of annual increase in ozone attributable to foreign

sources). Furthermore, by requiring States to show that international

transport is the “but for” cause of nonattainment, these provisions fail

to provide relief for situations where multiple background sources

contribute to nonattainment.

By relying on these provisions to justify its rule, EPA attempts to

duck its responsibility under the Act to take into account whether its

NAAQS is achievable. Rather than the Agency “meet[ing] its obligation

to explain and expose every step of its reasoning,” Mississippi, 744 F.3d

at 1349 (quotation omitted), EPA’s reliance on Section 7509a is an

impermissible attempt to impose on States the task of showing why

achievability is impossible. The Act does not countenance this inversion

of its relief measures.

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2. Where They Apply, the Relief Measures Are

Inadequate Solutions to the Problem of Uncontrollable

Background Ozone.

Common to all of the enforcement-stage “tools” is their

dependence on EPA’s discretion. 42 U.S.C. § 7511a(h)(1) (“in the

Administrator’s discretion”); 42 U.S.C. § 7509a(b) (“to the satisfaction of

the Administrator”). The discretionary nature of this relief renders it

onerous to request, uncertain to obtain, and nearly impossible to

challenge if denied. Utah, for example, has invested 4,000 hours since

2008 preparing a dozen exceptional event demonstrations that EPA has

denied. Bennett Comment at 15 (JA__). Other States, like Nevada,

have concluded that they lack the resources necessary to prove an

exceptional event. Id. Even if a State shoulders the immense cost and

lodges a request, EPA concedes that “few” nonattainment areas have

ever obtained relief. 79 FR 75,384 (JA__). This admission is consistent

with the experience of Wyoming, which has filed 25 exceptional event

applications since 2012; EPA has granted only one. Bennett Comment

at 14 (JA__); Wyoming DEQ (JA__). The Agency also has discretion in

recognizing rural transport areas and has designated only four such

areas in history, none of them for the 8-hour ozone NAAQS. 80 FR

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65,438 & n.235 (JA__). Finally, EPA also has unfettered discretion to

decide whether a State has made the required “but for” showing to

qualify for the international transport provisions. See 42 U.S.C.

§ 7509a(a).

Because discretionary relief is uncertain, these tools do not

provide the States any assurance that they will be able to fulfill their

responsibility for ensuring that NAAQS be “achieved and maintained.”

42 U.S.C. § 7407(a). They are therefore no substitute for an achievable

standard that addresses the issue of uncontrollable background ozone.

Even under the best of circumstances—when States can devote

resources to seeking relief and EPA agrees to the request—the relief

provided is incomplete. A rural transport area, for example, must still

complete a “comprehensive, accurate, current inventory of actual

emissions from all sources,” and must still comply with the onerous

New Source Review permitting process “for the construction and

operation of each new or modified major stationary source.” 42 U.S.C.

§§ 7511a(a)(1), 7511a(a)(2)(C). Likewise, an area that satisfies the

international transport requirements obtains relief from three

provisions of the CAA, 42 U.S.C. § 7509a(b), but remains a

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“nonattainment” area and therefore faces mandatory emission control

measures and must meet special emission reduction targets, 79 FR

75,384 (JA__). These “remedies” are no substitute for a proper NAAQS.

Additionally, case-by-case discretionary relief creates obstacles for

obtaining judicial review. Unlike the rulemaking at issue in this

litigation, an EPA decision to deny relief under the foregoing

mechanisms would take the form of an individual adjudication. In that

posture, courts defer to the agency both on its fact-finding, see NLRB v.

Brown, 380 U.S. 278, 292 (1965), and on the application of law to facts,

see Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416

(1971). In fact, none of the State Petitioners is aware of a case in which

EPA denied relief under any of the three provisions and a court later

reversed that decision. This extreme deference undermines EPA’s

argument that potential enforcement-stage relief is a substitute for

enacting an achievable standard in the first place. By attempting to

channel objections to the impossibility of compliance through

adjudications, EPA endeavors to stack the deck in its favor, all while

maintaining that this mechanism is itself a reason for this Court to

rubberstamp an unachievable NAAQS.

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EPA cannot redeem a rule that is unlawful by pointing to

statutory “tools” that are cumbersome, discretionary, and, in any event,

cannot provide adequate relief. The CAA’s provisions for exceptional

events and rural and international transport are supposed to apply

under rare circumstances. This Court should not read these provisions

to cannibalize the more foundational principles of their parent statute,

including the requirement that NAAQS be “achiev[able].” EPA’s

reliance on these relief measures as a justification for its failure to

account for background ozone is arbitrary, capricious, and inconsistent

with the Clean Air Act as a whole.

II. Under EPA’s Construction of the Act, the NAAQS Review Process

Would Lack an “Intelligible Principle.”

Because Article I provides that “[a]ll legislative Powers herein

granted shall be vested in a Congress of the United States,” U.S. Const.,

art. I, § 1, courts have insisted that Congress cannot delegate its

legislative power. Field v. Clark, 143 U.S. 649, 692 (1892). So long as

Congress provides “an intelligible principle” for an agency to follow,

however, “such legislative action is not a forbidden delegation of

legislative power.” J.W. Hampton, Jr., & Co. v. United States, 276 U.S.

394, 409 (1928).

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In Whitman, the Supreme Court found an “intelligible” principle

in the language of the Act itself—“requisite”—which the Court defined

as “not lower or higher than is necessary.” 531 U.S. at 475-76. But for

that “principle” to be truly “intelligible,” EPA must also apply it in a

way that is intelligible. Otherwise, the principle identified by the

Supreme Court in Whitman would dissolve in EPA’s semantics, which

was precisely what concerned this Court in ATA I:

For EPA to pick any non-zero level it must explain the

degree of imperfection permitted. The factors that EPA has

elected to examine for this purpose in themselves pose no

inherent nondelegation problem. But what EPA lacks is any

determinate criterion for drawing lines. It has failed to state

intelligibly how much is too much.

175 F.3d at 1034. In short, while Whitman held that EPA cannot

supply a principle missing from the statute, the more relevant question

here is whether EPA has “conform[ed]” to, not merely restated and then

ignored, the “intelligible” principles that Congress provided. See J.W.

Hampton, 276 U.S. at 409.

The new ozone NAAQS demonstrates how EPA’s current

interpretation of Section 109(d) of the CAA, 42 U.S.C. § 7409(d), would

in effect violate the nondelegation doctrine essential to the separation of

powers embedded in the Constitution. Specifically, EPA’s

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interpretation ignores several ways that EPA could give meaning to the

principle identified in Whitman, including (i) ensuring standards are

achievable, (ii) explaining any departures from prior standards, and (iii)

considering potential detriment to “public health” from a standard that

is too low. EPA’s failure to give any true meaning to its invocation of

Whitman has left EPA “free to pick any point between zero and a hair

below the concentrations yielding London’s Killer Fog.” ATA I, 175 F.3d

at 1037.

EPA’s evaluation of the 1997 ozone standard—the standard at

issue in Whitman—confirms that Whitman is not as infinitely

malleable as EPA now suggests. In crafting the 1997 standard, EPA

recognized that background levels provided a reasonable lower bound to

the analysis, a concept this Court accepted as relevant in upholding

EPA’s decision not to lower the standard to 70ppb. Am. Trucking, 283

F.3d at 379 (on remand after Whitman). Likewise, Judge Tatel, in

dissenting from the initial panel decision that was overturned by

Whitman, agreed with EPA that its decision was well-reasoned, in part

because EPA “set the ozone level just above peak background

concentrations.” 175 F.3d at 1061 (Tatel, J., dissenting in part). Thus,

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at least one lower bound on EPA’s standard-setting authority was well-

understood and real—EPA would not set a standard that could be

violated by “uncontrollable natural levels of ozone;” that would be too

low, and therefore not “requisite” under Whitman.

Thus, in context, the holding in Whitman found an intelligible

principle (“requisite . . . not lower or higher than is necessary”) and EPA

gave that principle meaning and effect (a standard below peak

background is too low). Here, in contrast, EPA has jettisoned that

lower bound.

EPA also appears to have abandoned any meaningful attempt to

allow prior standards to serve as a lower bound, at least in cases where

EPA cannot articulate a meaningful reason for contradicting its prior

analysis. To be sure, the determination of a certain standard as

“requisite” on one date does not make that assessment “sacrosanct . . .

until every aspect of it is undermined.” Mississippi, 744 F.3d at 1343

(2013). However, EPA must nevertheless explain any direct

contradiction of its prior analysis, id., and the decision to lower the

standard itself must also be “appropriate,” 42 U.S.C. § 7409(d)(1). But

when commenters pointed out that EPA itself agreed in 1997 that

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70ppb would be too close to peak background levels, EPA’s only

response was to claim that a standard of 65ppb would present an even

greater concern. See Response to Comments at 350 (JA__). The failure

to directly answer the question exposes EPA’s failure to conform to any

“intelligible principle” in crafting the new standard. The same

statutory provision cannot “intelligibly” mean that 70ppb was “lower …

than . . . necessary” in 1997, due to peak background levels, but

“appropriate” in spite of peak background levels in 2015, especially

when peak background levels have only increased.

Citing Whitman and other cases, EPA also ignores all cost

considerations. But ignoring all costs fails to give full effect to the

statute’s primary focus: “public health.” As noted in Whitman, the Act’s

primary instruction governing NAAQS standards is not just that they

be “requisite” in some undefined sense, but rather “requisite” to protect

“public health.” 42 U.S.C. § 7409(b)(1) (emphasis added). Because

“public health” is undefined, it must bear its “ordinary or natural

meaning.” FDIC v. Meyer, 510 U.S. 471, 476 (1994). When Congress

added the language “public health” in 1970, the authoritative public

health treatise defined that concept as “preventing disease, prolonging

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life, and promoting physical health and efficiency [through] the

development of social machinery which will ensure to every individual

in the community a standard of living adequate to the maintenance of

health.” Winslow at 28 (emphasis added). At a minimum, costs

imposed on industry and the States—the “social machinery” that EPA

regulates—influence the “standard of living” in the community. Justice

Breyer recognized this concept in his concurring opinion in Whitman,

noting that “requisite” protection of public health should not “lead to

deindustrialization” because “[p]reindustrial society was not a very

healthy society.” Whitman, 531 U.S. at 496 (Breyer, J., concurring).

Justice Breyer’s connection between a NAAQS’s impact on the

economy and its ability to serve the public health is not limited to the

word “requisite.” It is also present in the Act’s reference to “public

health.” Recognizing this feature of the statutory language not only

faithfully applies the law but also avoids a collision with the

Constitution’s assignment of legislative power to Congress alone.

Having eliminated “achievability,” unexplained contradictions of

prior determinations, and “public health” as principled boundaries on

how low a NAAQS should go, EPA has reduced the intelligible principle

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identified in Whitman to a nullity, particularly for a “non-threshold”

pollutant “that inflict[s] a continuum of adverse health effects at any

airborne concentration greater than zero.” Whitman, 531 U.S. at 475.

EPA’s application of Whitman thus results in a standard that has all

the hallmarks of an unconstitutional delegation of authority—an

unbounded, essentially legislative policy announcement of how low is

too low. If EPA is truly so unfettered in its application of the Act, then

a reevaluation of the constitutionality of Section 109(d) is warranted—

this time (and for the first time) in the context of a standard that fully

exposes EPA’s ability to interpret away whatever intelligible principle

the Supreme Court identified in Whitman.

III. EPA’s Reliance on a Single Clinical Study to Justify the New

NAAQS Is Arbitrary and Capricious.

The State Petitioners incorporate by reference the Industry

Petitioners’ argument that EPA has arbitrarily “changed the

conclusions it drew from the same basic scientific evidence” available in

2008. See Indus. Pet. Br. 36-41. To that convincing exposition, the

States add only that the 2009 Schelegle study does not bear the weight

EPA places on it.

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EPA recognizes the weaknesses in the Schelegle study, noting

that, as several commenters pointed out: (1) “lung function decrements

and respiratory symptoms . . . were not correlated with each other;” (2)

average “decrements observed following exposures below 75 ppb are

small (e.g., < 10% . . .);” and (3) the lung-capacity limitations observed

were “transient and reversible, do not interfere with daily activities,

and do not result in permanent respiratory injury.” 80 FR 65,330.

In response, EPA infers from the American Thoracic Society’s

silence that ATS’s requirement of both decrements and symptoms “is

not restricted to effects of a particular magnitude nor a requirement

that individual responses be correlated.” Id. (emphasis added); see also

id. (“Similarly, CASAC made no such qualification”). This position is

unreasonable on both counts, regardless of whether EPA chooses to

focus on average or individualized data. If focused on average data,

Schelegle’s 6% average decrements fall well short of the 10% minimum

that EPA requires. If individual data are controlling, meaning that six

of the 31 study participants satisfy the 10% threshold, those six

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individuals are not the same people who reported symptoms.5 EPA’s

claim that CASAC does not expressly forbid bundling decrements from

one person with symptoms from another is also inconsistent with the

requirement of both decrements and symptoms before finding an

“adverse health effect,” a concept that is necessarily tied to individual

human bodies. The effect on individuals is, moreover, precisely the

reason why EPA prioritizes controlled human-exposure studies over

less reliable epidemiological evidence. Mississippi, 744 F.3d at 1343-44;

73 FR 16,479; 79 FR 75,288.

Either way, EPA must explain its choice. It is arbitrary and

capricious to rely on uncorrelated individual results and a too-low

average decrement based on ATS’s failure to foreclose this particular

portmanteau of unpersuasive data.

Ultimately, the 2009 Schelegle study does not present any new

information on the effects of ozone. Additionally, EPA has not offered a

reasoned explanation for how the study’s predictable findings justify a

lower NAAQS under the scientific framework the Agency itself

5 Additionally, EPA would need to provide a non-arbitrary explanation

for how this tiny group—six of 31 participants—is compelling evidence

today, when six of 30 was unconvincing in 2008.

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endorses. It is arbitrary and capricious for EPA to dismiss the

Schelegle study’s limitations in the manner it has.

CONCLUSION

EPA’s hastily-crafted ozone NAAQS imposes an unachievable

standard, divorced from the scientific realities of background ozone.

The Agency’s only response is to promise a partial accommodation that

the statute limits in both applicability and degree of relief. This model

of rulemaking does not accord with the Clean Air Act, which demands

that NAAQS be achievable. To abandon that expectation and instead

impose standards that would require cessation of human activity across

large parts of the country is either an abuse of discretion or proof that

EPA’s construction of the Act does not reflect an intelligible principle.

This Court should vacate the Rule.

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April 22, 2016

s/ Misha Tseytlin .

Brad D. Schimel

Attorney General Misha Tseytlin

Solicitor General Counsel of Record

Daniel P. Lennington

WISCONSIN DEPARTMENT OF

JUSTICE

17 W. Main Street

Madison, WI 53707

(608) 267-9323

Counsel for the State of Wisconsin

Respectfully Submitted,

s/ Dominic E. Draye .

Mark Brnovich

Attorney General John R. Lopez, IV

Solicitor General Dominic E. Draye

Deputy Solicitor General Counsel of Record Keith Miller

OFFICE OF THE ATTORNEY GENERAL

1275 W. Washington Street

Phoenix, AZ 85007

(602) 542-8255

[email protected]

Peter S. Glaser

Carroll W. “Mack” McGuffey

Darren W. Dwyer

TROUTMAN SANDERS LLP

401 Ninth Street, N.W.

Washington, D.C. 20004

(202) 274-2952

Counsel for the State of Arizona

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 70 of 86

55

s/ Lee Rudofsky .

Leslie C. Rutledge

Attorney General Lee Rudofsky

Solicitor General Counsel of Record Jamie L. Ewing

Assistant Attorney General 323 Center Street

Suite 200

Little Rock, AR 72201

(501) 682-2637

Counsel for the State of Arkansas

s/ Joseph A. Newberg, II .

Andy Beshear

Attorney General Joseph A. Newberg, II

Assistant Attorney General Counsel of Record KENTUCKY OFFICE OF THE

ATTORNEY GENERAL

The Capitol Building

700 Capitol Avenue, Suite 118

Frankfort, Kentucky 40601

(502) 696-5611

Counsel for the Commonwealth of Kentucky

s/ Steven B. Jones .

Jeff Landry

Attorney General Steven B. “Beaux” Jones

Counsel of Record Duncan S. Kemp, IV

Assistant Attorneys General Louisiana Department of Justice

1185 North Third Street

Baton Rouge, LA 70802

(225) 326-6085

Counsel for the State of Louisiana

s/ Lara Katz .

Lara Katz

Assistant General Counsel Counsel of Record 1190 St. Francis Drive

Santa Fe, New Mexico 87505

(505) 827-2885

Counsel for New Mexico Environment Department

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 71 of 86

56

s/ Margaret I. Olson .

Wayne Stenehjem

Attorney General

Margaret I. Olson

Assistant Attorney General Counsel of Record 500 North 9th Street

Bismarck, ND 58501-4509

(701) 328-3640

Counsel for the State of North Dakota

s/ Matthew B. Miller .

Ken Paxton

Attorney General Jeffrey C. Mateer

First Assistant Attorney General Priscilla M. Hubenak

Chief, Environmental Protection Division Matthew B. Miller

Assistant Attorney General Counsel of Record Craig J. Pritzlaff

Assistant Attorney General OFFICE OF THE ATTORNEY GENERAL

OF TEXAS

ENVIRONMENTAL PROTECTION

DIVISION

P.O. Box 12548, MC-066

Austin, TX 78711-2548

(512) 463-2012

Counsel for the State of Texas

s/ P. Clayton Eubanks .

E. Scott Pruitt

Attorney General P. Clayton Eubanks

Deputy Solicitor General Counsel of Record

313 N.E. 21st St

Oklahoma City, OK 73105

(405) 521-3921

Counsel for the State of Oklahoma

s/ Parker Douglas .

Sean Reyes

Attorney General Parker Douglas

Chief Federal Deputy & General Counsel

Counsel of Record UTAH ATTORNEY GENERAL’S OFFICE

350 North State Street, Ste. 230

Salt Lake City, UT 84114-2320

(801) 538-9600

Counsel for the State of Utah

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 72 of 86

CERTIFICATE OF COMPLIANCE

1. This brief complies with the type-volume limitation of Fed. R. App.

P. 32(a)(7)(C) because this brief contains 9,639 words, excluding

the parts of the brief exempted by Fed. R. App. P. 32(a)(7)(B)(iii).

The total number of words contained in this brief and the Industry

Petitioners’ Brief is fewer than 19,000, per this Court’s Order of

March 9, 2016.

2. This brief complies with the typeface requirements of Fed. R. App.

P. 32(a)(5) and the type style requirements of Fed. R. App. P.

32(a)(6) because this brief has been prepared in a proportionally

spaced typeface using Microsoft Word 2010 in 14-point Century

type.

s/ Dominic E. Draye .

Dominic E. Draye

Deputy Solicitor General OFFICE OF THE ATTORNEY GENERAL

1275 W. Washington Street

Phoenix, AZ 85007

(602) 542-8255

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 73 of 86

CERTIFICATE OF SERVICE

I hereby certify that I electronically filed the foregoing with the

Clerk of the Court for the United States Court of Appeals for the

District of Columbia Circuit by using the appellate CM/ECF system on

April 22, 2016. All participants in the case are registered CM/ECF

users and will be served by the appellate CM/ECF system.

s/ Dominic E. Draye .

Dominic E. Draye

Deputy Solicitor General OFFICE OF THE ATTORNEY GENERAL

1275 W. Washington Street

Phoenix, AZ 85007

(602) 542-8255

USCA Case #15-1385 Document #1610107 Filed: 04/22/2016 Page 74 of 86

Regulatory Addendum

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INDEX

40 C.F.R. § 50.14……………………………………………………………….3

40 C.F.R. § 50.19……………………………………………………………….9

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40 C.F.R. § 50.14 Treatment of air quality monitoring data influenced

by exceptional events.

(a) Requirements.

(1) A State may request EPA to exclude data showing exceedances or

violations of the national ambient air quality standard that are directly

due to an exceptional event from use in determinations by

demonstrating to EPA's satisfaction that such event caused a specific

air pollution concentration at a particular air quality monitoring

location.

(2) Demonstration to justify data exclusion may include any reliable

and accurate data, but must demonstrate a clear causal relationship

between the measured exceedance or violation of such standard and the

event in accordance with paragraph (c)(3)(iv) of this section.

(b) Determinations by EPA.

(1) EPA shall exclude data from use in determinations of exceedances

and NAAQS violations where a State demonstrates to EPA's

satisfaction that an exceptional event caused a specific air pollution

concentration in excess of one or more national ambient air quality

standards at a particular air quality monitoring location and otherwise

satisfies the requirements of this section.

(2) EPA shall exclude data from use in determinations of exceedances

and NAAQS violations where a State demonstrates to EPA's

satisfaction that emissions from fireworks displays caused a specific air

pollution concentration in excess of one or more national ambient air

quality standards at a particular air quality monitoring location and

otherwise satisfies the requirements of this section. Such data will be

treated in the same manner as exceptional events under this rule,

provided a State demonstrates that such use of fireworks is

significantly integral to traditional national, ethnic, or other cultural

events including, but not limited to July Fourth celebrations which

satisfy the requirements of this section.

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(3) EPA shall exclude data from use in determinations of exceedances

and NAAQS violations, where a State demonstrates to EPA's

satisfaction that emissions from prescribed fires caused a specific air

pollution concentration in excess of one or more national ambient air

quality standards at a particular air quality monitoring location and

otherwise satisfies the requirements of this section provided that such

emissions are from prescribed fires that EPA determines meets the

definition in § 50.1(j), and provided that the State has certified to EPA

that it has adopted and is implementing a Smoke Management

Program or the State has ensured that the burner employed basic

smoke management practices. If an exceptional event occurs using the

basic smoke management practices approach, the State must undertake

a review of its approach to ensure public health is being protected and

must include consideration of development of a SMP.

(4) [Reserved]

(c) Schedules and Procedures.

(1) Public notification.

(i) All States and, where applicable, their political subdivisions must

notify the public promptly whenever an event occurs or is reasonably

anticipated to occur which may result in the exceedance of an applicable

air quality standard.

(ii) [Reserved]

(2) Flagging of data.

(i) A State shall notify EPA of its intent to exclude one or more

measured exceedances of an applicable ambient air quality standard as

being due to an exceptional event by placing a flag in the appropriate

field for the data record of concern which has been submitted to the

AQS database.

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5

(ii) Flags placed on data in accordance with this section shall be deemed

informational only, and the data shall not be excluded from

determinations with respect to exceedances or violations of the national

ambient air quality standards unless and until, following the State's

submittal of its demonstration pursuant to paragraph (c)(3) of this

section and EPA review, EPA notifies the State of its concurrence by

placing a concurrence flag in the appropriate field for the data record in

the AQS database.

(iii) Flags placed on data as being due to an exceptional event together

with an initial description of the event shall be submitted to EPA not

later than July 1st of the calendar year following the year in which the

flagged measurement occurred, except as allowed under paragraph

(c)(2)(iv) or (c)(2)(v) of this section.

(iv) For PM2.5 data collected during calendar years 2004-2006, that the

State identifies as resulting from an exceptional event, the State must

notify EPA of the flag and submit an initial description of the event no

later than October 1, 2007. EPA may grant an extension, if a State

requests an extension, and permit the State to submit the notification of

the flag and initial description by no later than December 1, 2007.

(v) For lead (Pb) data collected during calendar years 2006-2008, that

the State identifies as resulting from an exceptional event, the State

must notify EPA of the flag and submit an initial description of the

event no later than July 1, 2009. For Pb data collected during calendar

year 2009, that the State identifies as resulting from an exceptional

event, the State must notify EPA of the flag and submit an initial

description of the event no later than July 1, 2010. For Pb data collected

during calendar year 2010, that the State identifies as resulting from

an exceptional event, the State must notify EPA of the flag and submit

an initial description of the event no later than May 1, 2011.

(vi) When EPA sets a NAAQS for a new pollutant or revises the NAAQS

for an existing pollutant, it may revise or set a new schedule for

flagging exceptional event data, providing initial data descriptions and

providing detailed data documentation in AQS for the initial

designations of areas for those NAAQS. Table 1 provides the schedule

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for submission of flags with initial descriptions in AQS and detailed

documentation. These schedules shall apply for those data which will or

may influence the initial designation of areas for those NAAQS. EPA

anticipates revising Table 1 as necessary to accommodate revised data

submission schedules for new or revised NAAQS.

Table 1—Schedule of Exceptional Event Flagging and Documentation

Submission for Data To Be Used in Designations Decisions for New or

Revised NAAQS

NAAQS

Pollutant/

standard/(level)/

promulgation

date

Air quality data

collected for

calendar year

Event flagging

& initial

description

deadline

Detailed

documentation

submission

deadline

PM2.5/24-Hr

Standard (35

µg/m3)

Promulgated

October 17, 2006

2004-2006 October 1,

2007 a April 15, 2008. a

Ozone/8-Hr

Standard (0.075

ppm)

Promulgated

March 12, 2008

2005-

20072008 2009

June 18,

2009 a

June 18,

2009 a

60 days after

the end of the

calendar

quarter in

which the

event occurred

or February 5,

2010,

whichever date

June 18, 2009 a

June 18, 2009 1

60 days after the

end of the

calendar quarter

in which the event

occurred or

February 5, 2010,

whichever date

occurs first.b

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occurs first b

NO2/1-Hour

Standard (80-100

PPB, final level

TBD)

2008 2009 2010

July 1, 2010 a

July 1, 2010 a

April 1, 2011 a

January 22,

2011 a

January 22, 2011 a

July 1, 2010 a

SO 2/1-Hour

Standard (50-100

PPB, final level

TBD)

20082009 2010

October 1,

2010 b

October 1,

2010 b

June 1, 2011 b

June 1, 2011 b

June 1, 2011 b

June 1, 2011 b

2011

60 days after

the end of the

calendar

quarter in

which the

event occurred

or March 31,

2012,

whichever date

occurs first b

60 days after the

end of the

calendar quarter

in which the event

occurred or March

31, 2012,

whichever date

occurs first. b

a These dates are unchanged from those published in the original

rulemaking, or are being proposed elsewhere and are shown in this

table for informational purposes—the Agency is not opening these

dates for comment under this rulemaking.

b Indicates change from general schedule in 40 CFR 50.14.

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Note:EPA notes that the table of revised deadlines only applies to data

EPA will use to establish the final initial designations for new or

revised NAAQS. The general schedule applies for all other purposes,

most notably, for data used by EPA for redesignations to attainment.

(3) Submission of demonstrations. (i) A State that has flagged data as being due to an exceptional event

and is requesting exclusion of the affected measurement data shall,

after notice and opportunity for public comment, submit a

demonstration to justify data exclusion to EPA not later than the lesser

of, 3 years following the end of the calendar quarter in which the

flagged concentration was recorded or, 12 months prior to the date that

a regulatory decision must be made by EPA. A State must submit the

public comments it received along with its demonstration to EPA.

(ii) A State that flags data collected during calendar years 2004-2006,

pursuant to paragraph (c)(2)(iv) of this section, must adopt the

procedures and requirements specified in paragraph (c)(3)(i) of this

section and must include a demonstration to justify the exclusion of the

data not later than the submittal of the Governor's recommendation

letter on nonattainment areas.

(iii) A State that flags Pb data collected during calendar years 2006-

2009, pursuant to paragraph (c)(2)(v) of this section shall, after notice

and opportunity for public comment, submit to EPA a demonstration to

justify exclusion of the data not later than October 15, 2010. A State

that flags Pb data collected during calendar year 2010 shall, after notice

and opportunity for public comment, submit to EPA a demonstration to

justify the exclusion of the data not later than May 1, 2011. A state

must submit the public comments it received along with its

demonstration to EPA.

(iv) The demonstration to justify data exclusion shall provide evidence

that:(A) The event satisfies the criteria set forth in 40 CFR 50.1(j);(B)

There is a clear causal relationship between the measurement under

consideration and the event that is claimed to have affected the air

quality in the area;(C) The event is associated with a measured

concentration in excess of normal historical fluctuations, including

background; and(D) There would have been no exceedance or violation

but for the event.

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(v) With the submission of the demonstration, the State must document

that the public comment process was followed.

[72 FR 13580, Mar. 22, 2007; 72 FR 28612, May 22, 2007; 73 FR

67051, Nov. 12, 2008; 74 FR 70598, Nov. 21, 2008; 74 FR 23312, May

19, 2009; 75 FR 6531, Feb. 9, 2010; 75 FR 35592, June 22, 2010]

40 C.F.R. § 50.19 Categorical exclusions not subject to the Federal laws

and authorities cited in § 50.4.

(a) General. The activities and related approvals of policy documents

listed in paragraphs (b) and (c) of this section are not subject to the

individual compliance requirements of the Federal laws and authorities

cited in § 50.4, unless otherwise indicated below. These activities and

approvals of policy documents are also categorically excluded from the

EA required by NEPA except in extraordinary circumstances (§

50.20(b)). HUD approval or implementation of these categories of

activities and policy documents does not require environmental review,

because they do not alter physical conditions in a manner or to an

extent that would require review under NEPA or the other laws and

authorities cited at § 50.4.

(b) Activities. (1) Environmental and other studies, resource identification and the

development of plans and strategies.

(2) Information and financial advisory services.

(3) Administrative and management expenses.

(4) Public services that will not have a physical impact or result in any

physical changes, including but not limited to services concerned with

employment, crime prevention, child care, health, drug abuse,

education, counseling, energy conservation and welfare or recreational

needs.

(5) Inspections and testing of properties for hazards or defects.

(6) Purchase of insurance.

(7) Purchase of tools.

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(8) Engineering or design costs.

(9) Technical assistance and training.

(10) Assistance for temporary or permanent improvements that do not

alter environmental conditions and are limited to protection, repair or

restoration activities necessary only to control or arrest the effects from

disasters or imminent threats to public safety including those resulting

from physical deterioration.

(11) Tenant-based rental assistance.

(12) Supportive services including, but not limited to, health care,

housing services, permanent housing placement, day care, nutritional

services, short-term payments for rent/mortgage/utility costs, and

assistance in gaining access to local, State, and Federal government

benefits and services.

(13) Operating costs including maintenance, security, operation,

utilities, furnishings, equipment, supplies, staff training and

recruitment and other incidental costs; however, in the case of

equipment, compliance with § 50.4(b)(1) is required.

(14) Economic development activities, including but not limited to,

equipment purchase, inventory financing, interest subsidy, operating

expenses and similar costs not associated with construction or physical

expansion of existing facilities; however, in the case of equipment

purchase, compliance with § 50.4(b)(1) is required.

(15) Activities to assist homebuyers to purchase existing dwelling units

or dwelling units under construction, including closing costs and

downpayment assistance, interest buydowns, and similar activities that

result in the transfer of title.

(16) Housing pre-development costs including legal, consulting,

developer and other costs related to site options, project financing,

administrative costs and fees for loan commitments, zoning approvals,

and other related activities which do not have a physical impact.

(17) HUD's insurance of one-to-four family mortgages under the Direct

Endorsement program, the insurance of one-to-four family mortgages

under the Lender Insurance program, and HUD's guarantee of loans for

one-to-four family dwellings under the Direct Guarantee procedure for

the Indian Housing loan guarantee program, without any HUD review

or approval before the completion of construction or rehabilitation and

the loan closing; and HUD's acceptance for insurance of loans insured

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under Title I of the National Housing Act; however, compliance with §§

50.4(b)(1) and (c)(1) and 24 CFR 51.303(a)(3) is required.

(18) HUD's endorsement of one-to-four family mortgage insurance for

proposed construction under Improved Area processing; however, the

Appraiser/Review Appraiser Checksheet (Form HUD-54891) must be

completed.

(19) Activities of the Government National Mortgage Association under

Title III of the National Housing Act (12 U.S.C. 1716 et seq.). (20) Activities under the Interstate Land Sales Full Disclosure Act (15

U.S.C. 1701 et seq.).(21) Refinancing of HUD-insured mortgages that

will not allow new construction or rehabilitation, nor result in any

physical impacts or changes except for routine maintenance; however,

compliance with § 50.4(b)(1) is required.

(22) Approval of the sale of a HUD-held mortgage.

(23) Approval of the foreclosure sale of a property with a HUD-held

mortgage; however, appropriate restrictions will be imposed to protect

historic properties.

(24) HUD guarantees under the Loan Guarantee Recovery Fund

Program (24 CFR part 573) of loans that refinance existing loans and

mortgages, where any new construction or rehabilitation financed by

the existing loan or mortgage has been completed prior to the filing of

an application under the program, and the refinancing will not allow

further construction or rehabilitation, nor result in any physical

impacts or changes except for routine maintenance; however,

compliance with §§ 50.4 (b)(1) and (c)(1) and 51.303(a) is required.

(c) Approval of policy documents. (1) Approval of rules and notices proposed for publication in the Federal

Register or other policy documents that do not:(i) Direct, provide for

assistance or loan and mortgage insurance for, or otherwise govern or

regulate, real property acquisition, disposition, leasing (other than

tenant-based rental assistance), rehabilitation, alteration, demolition,

or new construction; or (ii) Establish, revise, or provide for standards for

construction or construction materials, manufactured housing, or

occupancy.

(2) Approval of policy documents that amend an existing document

where the existing document as a whole would not fall within an

exclusion in this paragraph (c) but the amendment by itself would do so;

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(3) Approval of policy documents that set out fair housing or

nondiscrimination standards or enforcement procedures or provide for

assistance in promoting or enforcing fair housing or nondiscrimination;

(4) Approval of handbooks, notices and other documents that provide

operating instructions and procedures in connection with activities

under a Federal Register document that has previously been subject to

a required environmental review.

(5) Approval of a Notice of Funding Availability (NOFA) that provides

funding under, and does not alter any environmental requirements of, a

regulation or program guideline that was previously published in

the Federal Register, provided that(i) The NOFA specifically refers to

the environmental review provisions of the regulation or guideline; or(ii)

The regulation or guideline contains no environmental review

provisions because it concerns only activities listed in paragraph (b) of

this section.

(6) Statutorily required and/or discretionary establishment and review

of interest rates, loan limits, building cost limits, prototype costs, fair

market rent schedules, HUD-determined prevailing wage rates, income

limits and exclusions with regard to eligibility for or calculation of HUD

housing assistance or rental assistance, and similar rate and cost

determinations and related external administrative or fiscal

requirements or procedures which do not constitute a development

decision that affects the physical condition of specific project areas or

building sites.

[61 FR 50916, Sept. 27, 1996, as amended at 62 FR 15802, Apr. 2,

1997; 63 FR 48990, Sept. 11, 1998; 68 FR 56127, Sept. 29, 2003]

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